(naproxen and esomeprazole magnesium)

Delayed Release Tablets

Read this Medication Guide before you start taking VIMOVO and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or your treatment.

What is the most important information I should know about VIMOVO?

VIMOVO, which contains naproxen [a nonsteroidal anti-inflammatory drug (NSAID)] and esomeprazole magnesium, may increase the chance of a heart attack or stroke that can lead to death. This chance increases:

with longer use of NSAID medicines

in people who have heart disease

NSAID-containing medicines, such as VIMOVO, should never be used right before or after a heart surgery called a coronary artery bypass graft (CABG).

NSAID-containing medicines, such as VIMOVO, can cause ulcers and bleeding in the stomach and intestines at any time during treatment. Ulcers and bleeding:

can happen without warning symptoms

may cause death

The chance of a person getting an ulcer or bleeding increases with:

taking medicines called steroid hormones (corticosteroids) and blood thinners (anticoagulants)

longer use

smoking

drinking alcohol

older age

having poor health

NSAID medicines should only be used:

exactly as prescribed

at the lowest dose possible for your treatment

for the shortest time needed

What are Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?

NSAID medicines are used to treat pain and redness, swelling, and heat (inflammation) from medical conditions such as:

different types of arthritis

menstrual cramps and other types of short-term pain

Who should not take a Non–Steroidal Anti–Inflammatory Drug (NSAID)?

Do not take an NSAID medicine:

if you had an asthma attack, hives, or other allergic reaction with aspirin or any other NSAID medicine

for pain right before or after heart bypass surgery

Tell your healthcare provider:

about all of your medical conditions

about all of the medicines you take. NSAIDs and some other medicines can interact with each other and cause serious side effects. Keep a list of your medicines to show to your healthcare provider and pharmacist.

if you are pregnant. NSAID medicines should not be used by pregnant women late in their pregnancy.

if you are breastfeeding. Talk to your healthcare provider.

What are the possible side effects of Non–Steroidal Anti–Inflammatory Drugs (NSAIDs)?

Serious side effects include:

heart attack

stroke

high blood pressure

heart failure from body swelling (fluid retention)

kidney problems including kidney failure

bleeding and ulcers in the stomach and intestine

low red blood cells (anemia)

life-threatening skin reactions

life-threatening allergic reactions

liver problems including liver failure

asthma attacks in people who have asthma
 Other side effects include:

stomach pain

constipation

diarrhea

gas

heartburn

nausea

vomiting

dizziness
 

Get emergency help right away if you have any of the following symptoms:

shortness of breath or trouble breathing

chest pain

weakness in one part or side of your body

slurred speech